Evaluating VR Therapy Using Cold Pressor Test
Using the Cold Pressor Test to Assess Effectiveness of Low-Cost, Immersive Virtual Reality Therapy
1 other identifier
interventional
48
1 country
2
Brief Summary
This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile phones can be used as a potential distractor from pain and thus would have clinical applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients undergoing painful or uncomfortable procedures. To do this, the investigators are asking volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either while playing an interactive virtual reality game on the headset, or while wearing a VR headset that is turned off as a control. The investigators will record the participants' tolerance to cold water as measured by how long the participants are able to keep their hand in the cold water.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Sep 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedStudy Start
First participant enrolled
September 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2018
CompletedJune 11, 2019
June 1, 2019
10 months
July 28, 2017
June 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Tolerance
Likert Scale, 0-10
10 minutes
Secondary Outcomes (3)
Pain threshold
10 minutes
maximal pain
10 minutes
Nausea
10 minutes
Study Arms (2)
Virtual Reality
EXPERIMENTALGoogle Cardboard Virtual Reality headset running an interactive game
Control
SHAM COMPARATORPowered down Google Cardboard Virtual Reality headset
Interventions
A cold ice water bath for use in pain/discomfort simulation
Eligibility Criteria
You may qualify if:
- Healthy adult Mayo Clinic students and employees
You may not qualify if:
- Participants who are known to be sensitive to VR technology and/or have undesirable reactions to VR technology (i.e. dizziness, motion sickness)
- Participants with significant alcohol/smoking histories, sickle cell anemia, history of previous myocardial infarction and/or coronary artery disease, malignant hypertension, metabolic
- dysfunctions, pregnancy, Raynaud's disease, epilepsy, severe mental disorders, chronic pain conditions, or diseases producing neuropathic pain
- Participants that have used drugs/alcohol the day prior to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janet Vittonelead
Study Sites (2)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55901, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet Vittone
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant, General Internal Medicine
Study Record Dates
First Submitted
July 28, 2017
First Posted
August 31, 2017
Study Start
September 10, 2017
Primary Completion
July 10, 2018
Study Completion
July 20, 2018
Last Updated
June 11, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share